• Title/Summary/Keyword: Guideline

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Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] (간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Clinical Practice Guideline for Assessment and Prevention of Falls in Adult People (낙상위험요인 평가 및 낙상예방활동 임상진료지침)

  • Chun, Ja-Hae;Kim, Hyun-Ah;Kwak, Mi-Jeong;Kim, Hyuo-Sun;Park, Sun-Kyung;Kim, Moon-Sook;Choi, Ae-Lee;Hwang, Jee-In;Kim, Yoon-Sook
    • Quality Improvement in Health Care
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    • v.24 no.2
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    • pp.41-61
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    • 2018
  • Purpose: Falls are one of the most frequent health events in medical institutions, however, they can be predicted and prevented. The Quality Improvement Nurse Society clinical practice guideline Steering Committee developed the Clinical Practice Guideline for the assessment and prevention of falls in adult people. The purpose of this study was to assess the risk factors for falls in adults aged 19 years and older, to present an evidence for preventing falls, formulate a recommendations, and indicators for applying the recommendations. Methods: This clinical practice guideline was developed using a 23-step adaptation method according to the Handbook for clinical practice guideline developer (version 1.0) by National Evidence-based Healthcare Collaborating Agency. Evidence levels and recommendation ratings were established in accordance to SIGN 2011 (The Scottish Intercollegiate Guidelines Network). Results: The final 15 recommendations from four domains were derived from experts' advice; 1) assessment of risk factor for falls in adult 2) preventing falls and reducing the risks of falls or falls-related injury 3) management and reassessment after a person falls 4) leadership and culture. Conclusion: This clinical practice guideline can be used as a basis for evaluation and prevention of fall risk factors for adults, to formulate recommendations for fall risk assessment and fall prevention, and to present monitoring indicators for applying the recommendations.

Suggestions for developing Korean Medicine Clinical Practice Guideline for Allergic Rhinitis - Based on 2018 Chinese Clinical Practice Guideline (알레르기 비염 한의표준임상진료지침 방향 제언 - 2018 중국 임상진료지침을 바탕으로)

  • Kang, Jeong-In;Lee, Dong-Hyo
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.4
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    • pp.130-140
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    • 2019
  • Objective : The purpose of this study is to examine the treatment of allergic rhinitis introduced in the Chinese guideline, and to find out the direction of evidence-establishment and applicability in developing Korean Medicine clinical practice guideline for allergic rhinitis. Method : We studied Traditional Chinese Medicine treatment of allergic rhinitis introduced in the 2018 Chinese society of allergy guidelines for diagnosis and treatment of allergic rhinitis. The treatment are classified into three categories; herbal medicines, acupuncture and the others. And we compared this guidelines with other guidelines for how they differ in description of the database, evidence of level, and strength of recommendation. Results : Herbal medicines are presented based on syndrome differentiation. The basic acupoints for allergic rhinitis are introduced as follows; Fengchi(GB20), Yingxiang(LI20), Feishu(BL13) and Taiyuan(LU9). And in comparison with other guidelines for allergic rhinitis, the Chinese guideline showed lack of description in the database, evidence of level, and strength of recommendation, though they used evidence-based models. Conclusions : Clinical practice guideline projects are also underway in Korea for benefit expansion and improving quality of medical services. It is important to develop guidelines which should be evidence-based and reflect Korean medical environment.

Improvement of Charge Strength Guideline for Multi-Energy Method by Comparing Vapor Cloud Explosion Cases (증기운 폭발 사례 비교를 통한 멀티에너지법의 폭발강도계수 지침 개선)

  • Lee, Seung-Hoon;Kim, Han-Soo
    • Journal of the Computational Structural Engineering Institute of Korea
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    • v.34 no.6
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    • pp.355-362
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    • 2021
  • Various blast pressure calculation methods have been developed for predicting the explosion pressure of vapor cloud explosions. Empirical methods include the TNT equivalent method, and multi-energy method. The multi-energy method uses a charge strength that considers environmental factors. Although the Kinsella guideline was provided to determine the charge strength, there are limitations such as guidelines related to ignition sources. In this study, we proposed an improved charge strength guideline, by subdividing the ignition source intensity and expanding the type classification through literature analysis. To verify the improved charge strength guideline, and to compare it with the result obtained using the Kinsella guideline, four vapor cloud explosion cases which could be used to estimate the actual blast pressure were investigated. As a result, it was confirmed that the Kinsella guidelines showed an inaccurate, that is, wider pressure than the actual estimated blast pressure. However, the improved charge strength guideline enabled the selection of the intensity of the ignition source, and more subdivided types through the expansion of classification, hence it was possible to calculate the blast pressure relatively close to that of the actual case.

A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus (전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구)

  • Hansol Jang;U-Ryeong Chung;Jeong-Hyun Moon;Seong-Kyeong Choi;Won-Suk Sung;Min-Seop Hwang;Seung-Deok Lee;Kyung-Ho Kim;Jong-Hwa Yoon;Eun-Jung Kim
    • The Journal of Korean Medicine
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    • v.43 no.3
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    • pp.150-163
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    • 2022
  • Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

A Study on an acceptance of CDC guideline on practical emergency department planning -Focusing on comparison CDC guideline to Emergency Medical Service Act- (응급실에서의 감염관리 표준지침의 반영에 관한 연구 -응급실에서의 감염관리 표준지침과 응급의료에 관한 법률의 반영 비교를 중심으로-)

  • Yoon, Hyung Jin;Oh, Joon-Gul
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.16 no.11
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    • pp.7237-7243
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    • 2015
  • Korea Centers for Disease Control and Prevention(CDC) has been provided not only manual of managing infectious patient but also functional requirement of space in emergency department(ED) by distributing "Guideline for infection control in emergency department(GICED)" in 2009. To understand how much the guideline enforces its functional requirement on ED planning practice, it is compared to Emergency Medical Service Act(EMSA) a basic standard for ED planning. As a result, it is clear that those have different focal point in functional program and don't share infection control issue. By reviewing target hospitals' EDs opened around 2009, all ED have satisfied with the EMSA requirement but guideline. Those are selectively adapted infection control related spaces CDC guideline suggested regardless of open year so that target EDs are not to be influenced by the guideline. This research can support as a reference research when the EMSA are going to be reinforced by infection contol issue.

Adaptation of Isolation Guidelines for Health Care Settings (수용개작방법을 활용한 의료기관의 격리주의지침 개발)

  • Ryu, Jae Geum;Jeong, Jae Sim;Jeong, Ihn Sook;Kim, Jeong Hye;Hong, Eun-Young;Kim, Hyang Sook;Jung, Young Sun;Kwon, Jeong Soon;Lee, Ji Young;Choi, Ji Youn;Kim, Kyung Sug;Kim, Eun Hyun;Cha, Gyeong Suk;Kim, Eun Jin;Park, Kyung Hee;Seo, Hyun Ju
    • Journal of Korean Clinical Nursing Research
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    • v.24 no.2
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    • pp.209-226
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    • 2018
  • Purpose: This purpose of this study was to develop evidence-based practice guideline for isolation in health care settings to prevent transmission of infectious diseases utilizing guideline adaption process. Methods: The process of guideline adaptation was performed according to the Korean hospital nurses association's guideline adaptation manual which consisted of three main phases, 9 modules, and 24 steps. Results: The adapted isolation guideline consisted of introduction, overview of isolation guideline, summary of recommendations, recommendations, references, and appendices. The guideline includes 224 recommendations in 4 sections which are organizational administration, standard precautions, transmission-based precautions, and education/counselling. Conclusion: The adapted isolation guideline is recommended to be disseminated and utilized by nurses and clinicians nationwide to improve the isolation practices for infected or colonized patients with communicable diseases and to decrease the transmission of infections in the healthcare settings.

Updates of Evidence-Based Nursing Practice Guideline for Prevention of Venous Thromboembolism (근거기반 정맥혈전색전증 예방 간호실무지침 개정)

  • Cho, Yong Ae;Eun, Young;Lee, Seon Heui;Jeon, Mi Yang;Jung, Jin Hee;Han, Min Young;Kim, Nari;Huh, Jin Hyung
    • Journal of Korean Clinical Nursing Research
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    • v.29 no.1
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    • pp.24-41
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    • 2023
  • Purpose: This study aimed to update the previously published nursing practice guideline for prevention of venous thromboembolism (VTE). Methods: The guideline was updated according to the manuals developed by National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), and a Handbook for Clinical Practice Guideline Developer Version 10. Results: The updated nursing practice guideline for prevention of VTE was consisted of 16 domains, 46 subdomains, and 216 recommendations. The recommendations in each domain were: 4 general issues, 8 assessment of risk and bleeding factors, 5 interventions for prevention of VTE, 18 mechanical interventions, 36 pharmacological interventions, 36 VTE prevention starategies for medical patients, 25 for cancer patients, 13 for pregnancy, 8 for surgical patients, 7 for thoractic and cardiac surgery, 16 for orthopedic surgery, 10 for cranial and spinal surgery, 5 for vascular surgery, 13 for other surgery, 3 educations and information, and 2 documentation and report. For these recommendations, the level of evidence was 32.1% for level I, 51.8% for level II, and 16.1% for level III according to the infectious diseases society of America (IDSA) rating system. A total of 112 new recommendations were developed and 49 previous recommendations were deleted. Conclusion: The updated nursing practice guideline for prevention of VTE is expected to serve as an evidence-based practice guideline for prevention of VTE in South Korea. It is recommended that this guideline will disseminate to clinical nursing settings nationwide to improve the effectiveness of prevention of VTE practice.